12 Month Phase 3 Trial Finds Bronchitol Safe in Bronchiectasis
20 Agosto 2008 - 4:07AM
PR Newswire (US)
SYDNEY, Australia, Aug. 20 /Xinhua-PRNewswire-FirstCall/ --
Pharmaceutical company Pharmaxis (ASX:PXS)(NASDAQ:PXSL) today
announced that the Phase 3 clinical trial evaluating the long term
safety of Bronchitol in subjects with bronchiectasis has concluded
with no serious adverse events attributed to the drug following 12
months of treatment. A total of 123 subjects started treatment with
320 mg Bronchitol twice per day and 99 subjects completed the full
12 months of the trial. Of the 24 withdrawals, only seven were a
result of adverse events (three related to lung infections and two
related to cough). The most common adverse events attributed to
treatment were cough in 9% of the subjects and sore throat in 5%.
Other reported adverse events related to treatment were infrequent,
mild in severity and in most cases were a consequence of the
underlying disease. Pharmaxis CEO Alan Robertson said: "Pharmaxis
intends to file a marketing application in Australia for Bronchitol
as soon as possible now that this study has concluded
satisfactorily. "Bronchitol has created a great deal of interest
among people suffering with bronchiectasis and we continue to
respond to requests from trial participants and others interested
in Bronchitol. We are looking forward to bringing Bronchitol to the
market place and are delighted this trial has concluded
successfully." This 12 month treatment period was an open label
extension to a three month efficacy trial which reported in the
second half of 2007. The conclusion from this trial is that
Bronchitol improves quality of life and mucus clearance following
three months of treatment and is safe and well tolerated following
12 months of treatment. The open label component of the trial
reported today supports the efficacy reported earlier in the
blinded phase of the trial. Bronchitol is being initially developed
as a twice daily inhalation therapy for people with the incurable
lung conditions bronchiectasis and cystic fibrosis. It is estimated
that more than 600,000 in the major pharmaceutical markets suffer
from bronchiectasis and Pharmaxis expects Bronchitol to be the
first targeted medication for this patient group in 20 years,
addressing an important medical need. Total U.S. medical care
expenditure is US$13,000 per bronchiectasis patient, double that of
patients without the disorder; and an increased overall cost to the
US health system of US$630 million. Forward-Looking Statements The
statements contained in this media release that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements in this media release include statements
regarding our expectations, beliefs, hopes, goals, intentions,
initiatives or strategies, including statements regarding the
potential for Aridol and/or Bronchitol. All forward-looking
statements included in this media release are based upon
information available to us as of the date hereof, and we assume no
obligation to update any such forward-looking statement as a result
of new information, future events or otherwise. We can not
guarantee that any product candidate will receive FDA or other
regulatory approval or that we will seek any such approval. Factors
that could cause or contribute to such differences include, but are
not limited to, factors discussed in the "Risk Factors and Other
Uncertainties" section of our Form 20-F lodged with the U.S.
Securities and Exchange Commission. CONTACT: Alan Robertson Chief
Executive Officer Tel: +61-2-9454-7200 Email: RELEASED THROUGH:
Australia: Virginia Nicholls Tel: +61-417-610-824 Email: United
States: Brandon Lewis, Trout Group Tel: +1-646-378-2915 Email:
DATASOURCE: Pharmaxis Ltd CONTACT: Alan Robertson, Chief Executive
Officer of Pharmaxis, +61-2-9454-7200,
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